Active — Not RecruitingPhase 2

Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer

United States162 participantsStarted 2010-02-04

Plain-language summary

To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4) when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian cancer.

Who can participate

Age range18 Years – 125 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosed with serous ovarian cancer * Patients who have received no more than 3 previous platinum containing treatments and were progression free for at least 6 months following the end of the last platinum treatment * At least one lesion that is suitable for accurate repeated measurements Exclusion Criteria: * Patients receiving any systemic anticancer chemotherapy, radiotherapy (except palliative) within two weeks from the last dose prior to study treatment * Hypersensitivity to pre medications required for treatment with paclitaxel/carboplatin

What they're measuring

Progression Free Survival (PFS)

Timeframe: Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months)

Trial details

NCT IDNCT01081951

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-10-10

Results submitted2012-11-12

View on ClinicalTrials.gov More Ovarian Cancer trials